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Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery

20 de septiembre de 2021 actualizado por: Ryan McMillen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis

The primary objective of this study is to determine whether immediate weight-bearing following foot and ankle surgery provides similar or superior results to the traditional non-weight-bearing post-operative course, while reducing the disuse atrophy and length of rehabilitation necessary to recover during the transition to weight-bearing following an extended course of non-weight-bearing. This will be done by way of clinical follow-up, serial radiographs and/or other appropriate imaging modalities, and patient reported outcomes by way of AOFAS and SF-36 surveys.

Descripción general del estudio

Estado

Terminado

Condiciones

Cirugía de pie y tobillo

Intervención / Tratamiento

Descripción detallada

The study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two groups; an immediate weight-bearing group or a non-weight-bearing group. The patients will be randomly placed into the study group and control group if they meet all eligibility criteria.

This study will be conducted at 5 investigative clinic sites; West Penn Hospital, Forbes Regional Hospital, Jefferson Regional Hospital, Bethel Park Surgery Center, and Monroeville Surgery. Recruitment will stop when a minimum of 230 subjects are consented.

The study duration will require 7 visits to the clinic plus a surgery day therefore will require a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative visits to the clinics. The entire follow up period will occur over 2 years.

Tipo de estudio

Intervencionista

Inscripción (Actual)

Fase

No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Estados Unidos
- Pennsylvania
  - Clairton, Pennsylvania, Estados Unidos, 15025
    - Steel Valley Orthopaedic and Sports Medicine
  - Pittsburgh, Pennsylvania, Estados Unidos, 15224
    - The Foot & Ankle Institute/Western Pennsylvania Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 89 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Males or females age 18 to 89 years
Undergoing foot and ankle surgery
Must be able to read and understand English and consent for themselves

Exclusion Criteria:

Diagnosed peripheral neuropathy
Diagnosed peripheral vascular disease
Documented infection to the surgical extremity
Previous surgery to the surgical limb
Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union
Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Ninguno (etiqueta abierta)

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Otro: Immediate protected weight-bearing	Otro: Weight Bearing Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery Otros nombres: Cojinete de peso temprano
Otro: Traditional non weight bearing Strict non-weight-bearing	Otro: Strict non-weight bearing Strict non weight bearing for 6 weeks following foot & ankle surgery Otros nombres: Non-weight bearing

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Periodo de tiempo: Both Arms: Screening	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Screening
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Periodo de tiempo: Both Arms: Post-operative 6-8 weeks	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Post-operative 6-8 weeks
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Periodo de tiempo: Both Arms: Post-operative 3 month	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Post-operative 3 month
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Periodo de tiempo: Both Arms: Post-operative 12 month	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Post-operative 12 month
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Periodo de tiempo: Both Arms: Post-operative 24 month	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Post-operative 24 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Periodo de tiempo: Both Arms: Screening	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Screening
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Periodo de tiempo: Both Arms: Post-operative 6-8 weeks	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Post-operative 6-8 weeks
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Periodo de tiempo: Both Arms: Post-operative 3 month	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Post-operative 3 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Periodo de tiempo: Both Arms: Post-operative 12 month	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Post-operative 12 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Periodo de tiempo: Both Arms: Post-operative 24 month	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Post-operative 24 month

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Screening	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Screening
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 2-3 weeks	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 2-3 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 6-8 weeks	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 6-8 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 3 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 3 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 6 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 6 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 12 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 12 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 24 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 24 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Screening	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Screening
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 2-3 weeks	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 2-3 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 6-8 weeks	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 6-8 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 3 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 3 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 6 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 6 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 12 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 12 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Periodo de tiempo: Both arms: Post-operative 24 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 24 month

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Investigadores

Investigador principal: Ryan L. McMillen, DPM, FACFAS, Steel Valley Orthopaedic & Sports Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de julio de 2019

Finalización primaria (Actual)

15 de julio de 2021

Finalización del estudio (Actual)

15 de julio de 2021

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2019

Primero enviado que cumplió con los criterios de control de calidad

21 de junio de 2019

Publicado por primera vez (Actual)

25 de junio de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de septiembre de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

20 de septiembre de 2021

Última verificación

1 de septiembre de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

2019-124JH

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Principal Investigator and Co-Investigators are part of the Allegheny Health Network and will have complete access to all data for the purpose of publication at study completion. No other outside entities are involved in this research study.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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